MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PATIENT TRACKER; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9734887

Device Problem Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

The system was serviced in the field and passed all tests.No failures were found.(b)(4) are applicable.The tracker was returned and analyzed.The tracker had no apparent physical damage and no signed of burning.When connected to a known good system, the tracker was identified but would not track.It displayed only a red status despite all three coils firing.(b)(4) are applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery (fess).It was reported that after the case they had noticed that the patient tracker had burned the patient.It was reported that "mr" conditions were not followed and that the nurse stated they did not coil the wire.They ran the wire straight towards the patient's foot.Imaging protocol with the patient trackers were provided to the site to confirm if it was followed in the case.The nurse had noticed that the coil they placed right before the scan was directly on top of the patient tracker.There was no delay and the patient impact is currently unknown.

Event Description

It was later noted that there was no other impact to the patient outside of the burn.The mr settings that was used was the settings that were recommended in the product packaging.It was confirmed that the patient tracker was attached to the patient's forehead.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PATIENT TRACKER
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10158089
• MDR Text Key: 195273370
• Report Number: 1723170-2020-01672
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• PMA/PMN Number: K141833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/26/2022
• Device Model Number: 9734887
• Device Catalogue Number: 9734887
• Device Lot Number: 191227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 06/16/2020
• Supplement Dates FDA Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 150